Kornimate/medical-research-clean huggingface dataset:
a clinical study of tqb3824 in subjects with advanced cancer

Conditions: Advanced Cancer

Summary: tqb3824 blocks function of a specific protein called cell division cycle 7 (cdc7) kinase in the human body, which plays important roles in the maintenance of dna replication forks and dna damage response pathways. this study will evaluate the safety, tolerability and pharmacokinetics of tqb3824.


Eligibility criteria:
inclusion criteria: 1. understood and signed an informed consent form; 2. eastern cooperative oncology group (ecog) performance status score of 0 to 1; 3. life expectancy \>=3 months; 4. progressed after standard treatment or no standard treatment with an established survival benefit is available; 5. adequate organ/system function; 6. female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped. exclusion criteria: 1. diagnosed and/or treated additional malignancy within 3 years before the first dose; 2. with factors affecting oral medication; 3. toxicity that is \>=grade 2 caused by previous cancer therapy; 4. received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose; 5. arterial thromboembolism and/or venous thromboembolism within 6 months; 6. a history of psychotropic drug abuse or have a mental disorder; 7. any severe and/or uncontrolled disease; 8. has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first dose; 9. has received chinese patent medicines with anti-tumor indications that national medical products administration (nmpa) approved within 2 weeks before the first dose; 10. has received cdc7 inhibitors; 11. pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage; 12. brain metastases ; 13. has participated in other clinical studies within 4 weeks before the first dose; 14. according to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
immunologic signatures following surgery for pancreatic cancer

Conditions: Pancreatic Cancer; Surgery

Summary: the goal of this pilot study is to evaluate and describe the immunologic and overall outcomes of subjects who undergo routine pancreatectomy with or without irreversible electroporation (ire) for pancreatic cancer. immunologic markers in the blood will be measured at several time points before and after surgery to determine if surgical approach is associated with different immunologic responses. secondary outcomes will include mortality and morbidity; operative time; blood loss and transfusion requirements; and oncologic outcomes such as: margin status, lymph node harvest, disease-free survival, and overall survival. analysis of immune response will help the investigator determine whether to expand the pilot into a larger study.

subjects will have blood draws at the following timepoints: pre-op, 1-2 days post-op, 3-5 days post-op, and 1-4 months post-op. at each timepoint, three 8.5ml acd (yellow top) vacutainer tubes will be drawn by the biobank and translational research core (brtc), study personnel, or hospital phlebotomists. the blood will be processed for pbmc isolation by brtc for dr. weinhold's laboratory and will be viable within 8 hours of draw. these timepoints for blood draws are at the same time as usual operative care and will not require additional visits on the part of the subject. for this study we will extensively utilize several polychromatic flow cytometry (pfc) platforms to follow activation, maturation, exhaustion, and proliferation patterns within cd4+ and cd8+ subsets of t-cells. we will also utilize an intracellular cytokine staining (ics) platform in efforts to detect anti-tumor associated antigen (taa) responses by cd4+ and cd8+ t cells from peripheral blood mononuclear cells (pbmc) as well as lymphocytes infiltrating the patient's tumor. these assays are designed to measure antigen-driven intracellular production of ifn-γ, tnf-α, and il-2, as well as the degranulation marker cd107. this strategy enables us to not only document individual cytokine responses, but to also assess (through boolean gating) changes in relative polyfunctionality of the responses.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age and at least the minimum age of majority according to applicable state or country law. * subject is a suitable surgical candidate, i.e., is able to undergo general anesthesia and pancreatectomy for diagnosis of cancer * subject is willing and able to undergo additional blood draws exclusion criteria: • subject is not a suitable candidate for surgery, or surgery is unable to be completed
comparison of postoperative visual acuity and spectacle independence between the tecnis multifocal intraoculer lens (iol) and the crystalens accommodating iol

Conditions: Cataract

Summary: comparison of postoperative visual acuity and spectacle independence between the tecnis multifocal intraoculer lens (iol) and the crystalens accommodating iol


Eligibility criteria:
inclusion criteria: * 18 years of age or older * status post bilateral cataract or refractive lens surgery (with or without lri) and implantation of tecnis™ multifocal iol or crystalens™ ao accommodating iol * best-corrected etdrs equivalent visual acuity of 20/30 or better in each eye * naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes * clear intraocular media (no posterior capsular opacification, or status post yag capsulotomy) * availability, willingness, and sufficient cognitive awareness to comply with examination procedures exclusion criteria: * ocular disease which could potentially limit uncorrected visual acuity or visual performance. * use of systemic or ocular medications that may affect visual outcomes * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.) * uncontrolled systemic or ocular disease * history of ocular trauma * history of ocular surgery other than that required for inclusion in this study * amblyopia or strabismus * known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) * diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30 * subjects who may be expected to require retinal laser treatment or other surgical intervention * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) * pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)
iron-biofortified rice intervention in the philippines

Conditions: Iron-deficiency; Anemia

Summary: the objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. a randomized trial of biofortified rice (ir68144-2b-2-2-3), bred to enhance iron content, was conducted among women living in convents in the greater area of manila, philippines for 9 months.

iron deficiency is the most prevalent nutritional deficiency globally, with the highest burden in women of reproductive age and children. in this randomized controlled trial, 317 women aged 18-45 years living in convents in the greater manila area, philippines, were fed meals using either biofortified or commercially available rice for all meals, 7 days a week, for 9 months. women living in convents in the greater manila area were recruited for this study. these women represent a segment of the population at high risk for iron deficiency, consume large quantities of rice, and all of their meals are prepared and consumed in common kitchen and dining areas, respectively. the investigators hypothesized that daily consumption of iron-biofortified rice (ir68144-2b-2-2-3) would improve hemoglobin, serum ferritin, and total body iron in 9 months, compared to control rice. in order to examine this hypothesis, the investigators conducted a randomized efficacy trial of iron-biofortified rice and iron status in among women living in convents in the greater area of manila, philippines for 9 months. the objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. the long-term goal of this study is to determine if iron bio-fortification of rice is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.

Eligibility criteria:
inclusion criteria: * women (18-45 years old) living in convents in the greater manila area * hb ≥10.5 g/dl exclusion criteria: * current or history of gastrointestinal or hematological disorders * taking iron supplements or medications that could interfere with hematopoiesis or dietary iron absorption * hb \<10.5 g/dl * women expressed uncertainty in their ability to participate for the full (9 month) trial

Keywords: anemia iron biofortification philippines iron deficiency women of reproductive age
minimally invasive fixation for distal radius fractures

Conditions: Distal Radius Fracture

Summary: minimally invasive surgery avoids the tissue damage and impairment of physiological function caused by open surgery because of its precise location techniques and can effectively promote the early recovery of wrist function. under conditions of no cutting of fracture fragments, no blood supply compromise in the fracture fragments

distal radial fracture is common fracture and internal fixation needed in many cases so we use minimally invasive fixation in this study to minimize open surgery compilations

Eligibility criteria:
inclusion criteria: 1. patients with unstable distal radial fracture 2. skeletally mature patients. 3. acute fractures within one weeks of injury exclusion criteria: 1. contaminated open fractures. 2. fractures associated with vascular injury requiring repair, and suspected pathologic fracture
90-day online substance use program

Conditions: Addictive Behavior; Alcohol Use Disorder; Alcohol Abuse; Drug Abuse; Drug Use Disorders

Summary: individuals indicating risky substance use are randomly assigned either to a three-month online intervention on the workit health platform or a waitlist/treatment as usual. those randomized to treatment will report reduced consumption of alcohol and other drugs and higher quality of life at study conclusion.


Eligibility criteria:
inclusion criteria: * subjects of this research are adults who self-identify as wanting to change their relationship to alcohol or drugs, who report currently using alcohol or drugs, or having recently stopped, who have access to an internet-enabled device, who are not currently suffering from untreated acute medical or psychiatric conditions, who anticipate being able to access the intervention over a six-month period, and who are able to freely consent to participate by themselves. exclusion criteria: * because the intervention is written for an adult audience, as well as the logistical challenges of having private access to an internet enabled device, this research is limited to participants over the age of 18.

Keywords: telemedicine online treatment digital intervention
uterus closure techniques and uterine niche formation

Conditions: Uterus; Scar

Summary: we aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (turan technique)

it is thought that the formation of the uterine niche may be mostly due to the surgical technique.we aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (turan technique).

Eligibility criteria:
inclusion criteria: * have a cesarean section necessity * be over 18 years old * being younger than 40 exclusion criteria: * emergency cesarean section * being under 37 weeks pregnant * multiple pregnancies * having had uterine surgery * uterine malformations
dietary challenges in the population of nursing homes' residents

Conditions: Nutritional Status; Nutrient Deficiency; Micronutrient Deficiency; Vitamin D Deficiency; Vitamin B 12 Deficiency; Folic Acid Deficiency; Iron-deficiency; Protein Deficiency; Sarcopenia; Obesity; Diet

Summary: to obtain up-to-date data on nutritional status of older adults, a national dietary survey will be conducted in 2022/2023, providing data on the consumption of foods and enabling the assessment intakes of energy and specific nutrients. participating subjects will be also screened for micronutrient status using blood biomarkers (focusing into vitamin d, folic acid, vitamin b12, and iron).


Eligibility criteria:
inclusion criteria: * age 65 years or older * has been in the elderly care institution (nursing home) for at least 3 months before joining the study * care category: i., ii., iii.a * the person can feed independently or with minimal help * agrees to be included in the study (signed a statement of consent) exclusion criteria: * the person has an acute illness * the person is a dialysis patient * temporary special diet / fasting / gastrointestinal cleansing (i.e. due to (pre)planned examinations / procedures) * the person cannot be weighted by the usual weighing scale or chair weighing scale * protégé of the day care center * located in the red zone of the elderly care institution (nursing home) (covid-19 measures)

Keywords: dietary intake nutritional status micronutrients slovenia europe
cancer of the lung and senescence - prospective cohort 1

Conditions: Non-Small Cell Lung Cancer

Summary: the main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve prognosis assessment older patients with locally or locally-advanced non-small cell lung cancer (nsclc).

geriatric assessment allows oncologists to stratify older cancer patients into risk categories (fit, vulnerable and frail) but few patients benefit from it. yet, they do not evaluate physiological reserves when oncologists are in dire need of quantitative tools accounting for age-related changes. this decade has witnessed the remarkable power of multiple tools (epigenetics, telomere integrity, cellular and immunosenescence) to estimate an individual's age. these tools hold the potential for routine implementation in the clinic and to be combined with existing tests. the main objective is to identify and assess the predictive value of ageing and senescence biomarkers (methylome, telomeres, inflammageing) and senescent cells in tissues to improve to improve prognosis assessment in older patients with locally or locally-advanced non-small cell lung cancer (nsclc). the ambition of this study is to refine the prognosis assessment and optimize decision-making process, better anticipate adverse-events and unplanned hospitalization and better manage and care high risk patients of early death, unplanned hospitalization, major complication or toxicities and altered quality of life.

Eligibility criteria:
inclusion criteria: * patients 70 years and over * local or locally advanced (stage i-iiia) nsclc * surgical curative intent * signed informed consent (or signed by the curator or tutorship) * affiliated to social security administrative care service exclusion criteria: * synchronous cancer * subject deprived of liberty by judicial or administrative decision or patient under guardianship * subject unable to understand the purpose and conditions of the study and unable to give consent

Keywords: non-small cell lung cancer aging biomarkers
food is medicine for patients with heart failure

Conditions: Heart Failure; Heart Failure，Congestive; Heart Diseases

Summary: this study will look at the effects of providing medically tailored meals (mtms) to people with heart disease for twelve weeks. the primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "healthy eating index."

this study will look at the effects of providing medically tailored meals (mtms) to people with heart disease for twelve weeks. sixty adults with heart failure will be recruited from the san diego and san francisco bay area of california. they will be randomly assigned to two groups: 1) a group that receives 15 "medically tailored meals" plus snacks each week for 12 weeks, 2) a group that receives 14 "medically tailored meals" each week for 12 weeks. the primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "healthy eating index". many other secondary outcomes will be assessed including both qualitative factors (e.g., satisfaction, preferences, adherence) and quantitative clinically measures (e.g., blood cholesterol, blood pressure, weight).

Eligibility criteria:
inclusion criteria: * willingness to comply with all study procedures and availability for the duration of the study * living in san diego or the bay area of california * reported congestive heart failure (chf) diagnosis * current diet can be improved * willing to eat all meals provided by the study exclusion criteria: * diagnosed with end-stage heart failure * diagnosed with diabetes (type 1 or uncontrolled type 2) * currently taking insulin and/or meglitinides medications * hemoglobin a1c (hba1c) results \>8 % * life expectancy of \<1 year * pregnancy or lactation * known severe allergic reactions and/or food intolerances that would interfere with the ability to eat study-provided meals, including foods that are prepared in a facility that works with the allergen * current smoker or tobacco use within the past year * planning to leave san diego or the bay area during the course of the study * unable to communicate reasonably well either orally or through written material in english * those who, in the opinion of the investigators, cannot reliably complete the study protocol
4 weeks treatment with empagliflozin (bi 10773) in japanese type 2 diabetic patients (t2dm)

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of bi 10773 administered for 28 days in japanese patients with t2dm.


Eligibility criteria:
inclusion criteria: 1. japanese male or female patients with t2dm treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones. 2. hemoglobin a1c (hba1c) at screening (visit 1) * for patients treated with 1 other oral antidiabetic drug: hba1c between 6.5% and 9.0%. * for patients not treated with any antidiabetic drug: hba1c between 7.0% and 10.0%. 3. age between 20 and 70 years 4. body mass index (bmi) between18.0 and 40.0 kg/m2 5. signed and dated written informed consent before admission to the trial in accordance with the good clinical practice (gcp) and the local legislation. exclusion criteria: 1. antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent 2. fasted blood glucose of \>240 mg/dl (\>13.3 mmol/l) or a randomly determined blood glucose level of \>400 mg/dl (22.2 mmol/l) on 2 consecutive days during wash-out period. 3. myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent. 4. clinically relevant concomitant diseases other than t2dm, hyperlipidaemia, and medically treated hypertension before the first administration such as * renal insufficiency (calculated estimated glomerular filtration rate \<60) * cardiac insufficiency of new york heart association (nyha) ii-iv or other known cardiovascular diseases including hypertension of \>160/95 mmhg, * neurological disorders (such as epilepsy) or psychiatric disorders * acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections) * any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder 5. patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.: * statins. * antihypertensives (diuretics not allowed) * alpha-blockers for benign prostate hypertrophy * occasional use of acetylsalicylic acid, ibuprofen, or paracetamol 6. additional inclusion/exclusion criteria apply
a dose-finding study of mal and hal photodynamic therapy of cervical premalignant lesions.

Conditions: Cervical Dysplasia

Summary: the study will determine the best drug (mal or hal) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).

surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. photodynamic therapy (pdt) is a selective, tissue preserving method that may become a good treatment option for these patients. this study will explore topical application of methyl aminolevulinate (mal) and hexaminolevulinate (hal) of the cervix for photodynamic therapy using red light (630 nm). different doses of mal and hal will be used with different application time, followed by illumination.

Eligibility criteria:
inclusion criteria: * positive histology of cin 1-3 exclusion criteria: * patients with endocervical lesions * patients with agus * patients with invasive disease * patients with porphyria * patients sensitive to mal and hal

Keywords: photodynamic therapy methyl aminolevulinate hexaminolevulinate dose-finding cervical dysplasia